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NCT07193862 · ClinicalTrials.gov registry record · Early Phase 1

Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

A Early Phase 1 study of Colorectal Cancer Metastatic, sponsored by Northwell Health.

Recruiting
Registry status
Early Phase 1
Development phase
10
Enrollment target
2
Study locations

NCT07193862 is a Early Phase 1 study of Colorectal Cancer Metastatic that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 10 participants, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT07193862, a Early Phase 1 study of Colorectal Cancer Metastatic, is actively recruiting participants, sponsored by Northwell Health.

RECRUITING
Registry status
Early Phase 1
Development phase
10 participants
Enrollment target
2
Study locations

Study Summary

Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.

Conditions Studied

Colorectal Cancer Metastatic

Interventions

  • COMBINATION_PRODUCT Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373

Study Locations (2)

New York

  • RJ Zuckerberg - Lake Success
  • Long Island Jewish Medical Center - New Hyde Park

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2025-12-10
Est. Completion 2026-04-15
Phase Early Phase 1

Sponsor

Northwell Health

370 total trials

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What the Registry Record Tells You About NCT07193862

The ClinicalTrials.gov registry entry for NCT07193862 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target (95% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Cancer Metastatic appearing as the primary indexed condition, and to 1 intervention - of which Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 is the first listed.

NCT07193862 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT07193862 about?

NCT07193862 is a clinical study titled "Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis". Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with...

What is the current status of trial NCT07193862?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2025-12-10. Estimated completion is 2026-04-15.

What conditions does trial NCT07193862 study?

This clinical trial studies the following conditions: Colorectal Cancer Metastatic.

What interventions are being tested in trial NCT07193862?

The interventions under investigation include: Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT07193862?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07193862 being conducted?

This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.